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- Tasks: Lead regulatory strategies for innovative diagnostics in oncology and collaborate with global teams.
- Company: Leica Biosystems, a forward-thinking company dedicated to advancing cancer diagnostics.
- Benefits: Comprehensive benefits package, including health coverage and opportunities for professional growth.
- Why this job: Make a real impact in cancer diagnostics while working with cutting-edge technologies.
- Qualifications: Bachelor's degree in science or engineering and extensive regulatory experience required.
- Other info: Dynamic work environment with opportunities for travel and career advancement.
The predicted salary is between 36000 - 60000 £ per year.
Overview
Principal, Regulatory Affairs role at Leica Biosystems – on-site in Newcastle, UK. This position is part of the Global Regulatory Affairs Team and reports to the Senior Manager, Regulatory Affairs.
The Principal, Regulatory Affairs is responsible for developing and executing global regulatory strategies for high-complexity diagnostics, including but not limited to IVDs, Companion Diagnostics and digital pathology in the clinical oncology space. This role partners with internal teams and external stakeholders to enable successful global commercialization of innovative technologies (including IDEs, Performance Study Applications, IVDR TF in the EU and 510(k)/PMA in the USA).
Learn about the Danaher Business System (DBS) which makes everything possible and the Leica Biosystems mission to advance cancer diagnostics and improve lives.
Responsibilities
- Serve as the Lead Regulatory Affairs representative on new product development teams for both IVD medical devices and RUO products.
- Develop and execute global regulatory strategies, including FDA 510(k), Pre-Submissions, Health Canada filings, and IVDR Technical File authoring.
- Provide regulatory guidance on product labeling, marketing materials, and product changes to ensure compliance.
- Collaborate cross-functionally with global teams and represent Regulatory Affairs on project teams, contributing regulatory intelligence and strategic input.
- Engage and negotiate with global regulatory agencies to achieve product clearance/approval, staying current on evolving regulations, guidance, and competitive landscapes.
- Share regulatory expertise across Leica and Danaher sites, contribute to cross-functional initiatives, and apply Danaher Business System (DBS) tools to drive continuous improvement and measurable results.
Essential requirements
- Bachelor’s degree in science or engineering or equivalent experience.
- Extensive experience with regulatory strategy and submissions for high-complexity diagnostic products in a global market; experience supporting clinical trials is a plus.
- In-depth working knowledge of FDA, Health Canada and EU regulatory requirements for IVD devices.
- Proven track record in developing and executing regulatory strategies and preparing global submissions for complex diagnostic products, including IVDR, 510(k), PMA, and Health Canada submissions.
- Strong analytical mindset with a continuous drive for regulatory intelligence and minimal supervision needed.
Travel and work environment
- Ability to travel – approximately 15% travel, with overnight stays as needed.
Preferred additional experience
- Applies deep regulatory expertise to development and global commercialization of complex, high-risk products, balancing short-term problem-solving with long-term strategic outcomes and risk-benefit analysis.
- Works effectively in matrixed and cross-cultural environments, driving timely decisions, issue resolution, and resource agility while modeling accountability and integrity.
- Communicates complex information clearly across diverse audiences, builds consensus, and demonstrates strong writing and documentation skills.
Leica Biosystems, a Danaher operating company, offers a broad array of comprehensive benefits. Learn more about benefits at Danaher Benefits Info. For more information, visit www.danaher.com.
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Principal, Regulatory Affairs employer: Leica Biosystems
Contact Detail:
Leica Biosystems Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal, Regulatory Affairs
✨Tip Number 1
Network like a pro! Reach out to people in the regulatory affairs field, especially those at Leica Biosystems or similar companies. A friendly chat can open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of FDA, Health Canada, and EU regulations. We want you to be able to discuss how your experience aligns with their needs, so practice articulating your regulatory strategies and successes.
✨Tip Number 3
Showcase your collaborative spirit! Highlight examples where you've worked cross-functionally or engaged with regulatory agencies. This will demonstrate that you're not just a regulatory whiz but also a team player who can drive results.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're genuinely interested in being part of the Leica Biosystems team.
We think you need these skills to ace Principal, Regulatory Affairs
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Principal, Regulatory Affairs role. Highlight your experience with regulatory strategies and submissions for high-complexity diagnostics, as this is key for us at Leica Biosystems.
Showcase Your Expertise: Don’t hold back on showcasing your in-depth knowledge of FDA, Health Canada, and EU regulations. We want to see how your expertise aligns with our mission to advance cancer diagnostics, so be specific about your past experiences.
Be Clear and Concise: When writing your application, clarity is crucial. Use straightforward language to communicate your achievements and skills. Remember, we appreciate strong writing and documentation skills, so make every word count!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Leica Biosystems
✨Know Your Regulatory Stuff
Make sure you brush up on the latest FDA, Health Canada, and EU regulations for IVD devices. Being able to discuss specific regulatory strategies and submissions will show that you're not just familiar with the basics but are ready to dive deep into the complexities of the role.
✨Showcase Your Collaboration Skills
Since this role involves working cross-functionally, be prepared to share examples of how you've successfully collaborated with different teams in the past. Highlight any experiences where you’ve engaged with regulatory agencies or contributed to project teams, as this will demonstrate your ability to work effectively in a matrixed environment.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or scenarios. Think about potential issues that could arise during product development and how you would navigate them. This will showcase your analytical mindset and problem-solving skills.
✨Communicate Clearly and Confidently
Practice articulating complex regulatory concepts in a way that's easy to understand. The interviewers will be looking for your ability to communicate clearly across diverse audiences, so consider doing mock interviews with friends or colleagues to refine your delivery.
